(RTTNews) - Veru Inc. (VERU), a late clinical-stage biopharmaceutical company, on Monday announced full enrollment in the Phase 2b Plateau study evaluating oral Enobosarm with Semaglutide in older adults with obesity. The study will assess the combination's effect on total body weight, fat mass, lean mass, physical function, bone mineral density and safety.
The Phase 2b Plateau trial was initiated following positive results from the Phase 2b Quality study, which showed that enobosarm preserved lean mass and improved fat loss when used with semaglutide in older adults.
According to the Centers for Disease Control and Prevention (CDC), about 41.5% of older adults who are obese may benefit from weight loss medications. However, up to 34.4% of obese older adults also have sarcopenic obesity, a condition marked by low muscle mass. When these patients receive currently approved GLP-1 RA weight loss treatments, they face an increased risk of muscle loss.
Enobosarm is an oral, selective androgen receptor modulator which is being developed as a treatment to augment fat loss and prevent muscle loss in sarcopenic obese individuals receiving a GLP-1 RA.
The Phase 2b Plateau trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3 mg with semaglutide in approximately 200 obese older adults.
The trial is designed to evaluate whether enobosarm can overcome the weight-loss plateau associated with GLP-1 therapy by preserving muscle mass and physical function while enabling additional weight reduction.
The primary endpoint is change in total body weight at 68 weeks, with secondary endpoints including fat mass, lean mass, physical function, mobility, bone mineral density, HbA1c and insulin resistance.
Veru expects interim results for the Phase 2b Plateau trial in the first quarter of 2027, following Topline data in the fourth quarter of 2027.
Veru shares closed Monday at $2.28, up 1.33%. In the overnight market, shares are trading down 0.44% at $2.27.
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